Category: Europe

Filing a Divisional Application in Europe – Part 15

March 2, 2021

This is the fifteenth post in our 16-part series examining divisional practice in Argentina, Brazil, Canada, China, Europe, India, Indonesia, Malaysia, Mexico, Pakistan, Russia, Thailand, Saudi Arabia, Singapore, the United States, and Vietnam (in no particular order).  Our first fourteen posts examining divisional practice in Brazil, Mexico, China, India, Argentina, Canada, Thailand, Pakistan, Malaysia, Singapore, Russia, Saudi Arabia and Vietnam and can be found here:  Divisional Practice – Brazil, Divisional Practice – Mexico, Divisional Practice – China, Divisional Practice – India, Divisional Practice – Argentina, Divisional Practice – Canada, Divisional Practice -Thailand,  Divisional Practice – Pakistan, Divisional Practice – Malaysia, Divisional Practice – Singapore, Divisional Practice in Russia, Divisional Practice in Saudi Arabia, Divisional Practice in Vietnam and Divisional Practice – United States.

Divisional applications in Europe

For European patent applications, a divisional application must be filed while a parent application is pending.  A parent application is no longer pending when it is granted, definitively refused or definitively withdrawn.  In other words, a patent application is considered pending:,

  1. Until the day before the date of publication of the mention of grant of the patent in the European Patent Bulletin;
  2. Until the last day of the period for filing an appeal (even if an appeal is not subsequently filed), when the Examining Division has refused the patent application; and if an appeal is filed, during the subsequent appeal proceedings;
  3. On the day the European Patent Office (EPO) receives a written request to withdraw a patent application; or
  4. Until the last day of a time limit; where non-observance of the time limit results in the application being “deemed withdrawn” with “a loss of rights”; such as, for example, due to: a failure to (a) pay a fee in due time; (b) file a translation of the claims; or (c) respond to a communication from the Examining Division with respect to an application’s deficiencies. However, if the Applicant takes steps to remedy the loss of rights (for example by filing a request for further processing and paying the relevant fees) then the application will be deemed to have been pending throughout the period.   It is important to note that if the parent application is a Europe-PCT (Euro-PCT) application, it must enter the European regional phase either before or together with the divisional application in order to be deemed pending.

Requirements for Filing a Divisional Application

According to Rule 40 of the European Patent Code (EPC), when filing a divisional application, the following must be supplied to the EPO:

  1. A written statement that an European patent is being sought;
  2. Information identifying the Applicant or allowing the Applicant to be contacted; and
  3. A description or reference to a previously filed application (A reference to a previously filed application must state the filing date and the number of the application and the Office in which it was filed.  Such reference must indicate that it replaces the description and any drawings).

When an application contains a reference to a previously filed application, a certified copy of the previously filed application must be filed within 2 months of the filing of a divisional application, unless the reference application was originally filed with the EPO.  If the previously filed application is not in an official language of the EPO (namely, in English, French or German), a translation into one of the official languages will be required within 2 months of the filing of the divisional application.

The filing and search fee for a divisional application must be paid within one month after filing.  The designation fee must be paid within 6 months of the date on which the European Patent Bulletin mentions the publication of the European search report for the divisional application.

Claims of a Divisional Application

A divisional application may be filed with or without any claims.  If a divisional application is filed without any claims, the EPO will set a 2-month period for the Applicant to provide a set of claims.  Alternatively, a divisional application may be filed with the claims as originally filed in the parent or Euro-PCT application.  However, the claims of a divisional application filed with the same claims of a parent or Euro-PCT application will need to be amended at some point during prosecution to ensure that neither the parent or divisional application claim the exact same subject matter from one another.

Double Patenting

The EPC does not explicitly contain any specific provisions prohibiting double patenting (namely, the case of co-pending European patent applications having the same filing date, filed by the same Applicant, and claiming the same subject matter).  However, the Guidelines for Examination in the EPO (Guidelines) in Section G-IV-5.4 state that “it is an accepted principle in most patent systems that two patents cannot be granted to the same application for one invention”.  In fact, the Enlarged Board of Appeal (Board) in decisions G 1/05 and G 1/06 accepted a prohibition on double patenting.  The reasoning the Board gave is that an Applicant does not have a “legitimate” interest in proceedings leading to the grant of a second patent for the same subject matter if the Applicant already possesses a granted patent for that same subject matter.  According to the Board, it is permissible to allow an Applicant to proceed with 2 applications having the same description provided that the claims are distinct in scope and directed to different inventions.

In view thereof, substantial overlap between claims has been permitted by the EPO.  For example, if claims to a narrow genus are obtained in a first application (such as a parent application), the EPO is likely to allow claims to a broader genus that encompasses the species in  a divisional application.   Specifically, the Guidelines in Section G-IV-5.4 state that:

“…in the rare case in which there are two or more European applications from the same applicant definitively designating the same State or States (by confirming the designation through payment of the relevant designation fee) and the claims of those applications have the same filing or priority date and relate to the same invention, the applicant should be told that he must either amend one or more of the applications in such a manner that the subject matter of the claims of the applications is not identical, or choose which one of those applications he wishes to proceed to grant.  If he does not do so, once one of the applications is granted, the other(s) will be refused under Art. 97(2) in conjunction with Art. 125.  If the claims of those applications are merely partially overlapping, no objection should be raised (see T 877/06).  Should two applications of the same effective date be received from two different applicants, each must be allowed to proceed as though the other did not exist” (emphasis added).

Therefore, practically speaking, an Applicant is unlikely to receive a double patenting objection by an Examiner in a divisional application provided that the Applicant can show that the claims in the divisional application do not contain the identical scope of the parent application.

Examination of Divisional Applications

A divisional application is treated as a separate application and is accorded a separate application number, requires separate fees, requires a separate request for examination, will be prosecuted separately from the parent application, and will result in an independent patent from the parent application.  The fees for a divisional application are the same as for any parent application.  The term of patent for a divisional application is twenty years from the filing date of the very first parent application.

Other Important Information Regarding Divisional Applications

Unlike other jurisdictions where divisional applications can only be filed when a lack of unity objection is raised by the relevant Office, European divisional applications can be filed at any time (namely, before receipt of the Search Report or issuance of any communication from the Examining Division).

Furthermore, unlike other jurisdictions where divisional applications can only be filed with claims directed to an invention other than the first invention identified by the relevant Office, European divisional applications can be filed (subject to the above considerations on double patenting) with claims directed to any subject matter, provided that the subject matter is literally supported by both the European divisional application as originally filed and the parent application(s) as originally filed.  In particular, divisional applications can be filed with claims directed to subject matter only disclosed in the description and/or drawings of the parent application even where the claims of the parent application were never directed to such subject matter.

When filing and/or subsequently amending a divisional application, care must be taken to avoid an  “extension of subject matter” beyond that disclosed in both the divisional application as filed and the parent application as filed, as well as the priority application, if its priority is claimed. The Examining Division will apply the so-called ‘gold-standard’ for determining what is disclosed, i.e., only subject matter “which is directly and unambiguously derivable from the disclosure of the invention in the priority and/or parent application (excluding the abstract, but including the drawings), also taking into account any features implicit to a person skilled in the art in what is expressly mentioned (see G 2/98)”.  Applicants are recommended to include all the subject matter disclosed in the parent application in the divisional application, for example, by including the claims of the parent application (in the form of clauses) in the description of the divisional application.

Additionally, Applicants must take care not to definitively delete any subject matter from a parent application (for example due to a unity objection), since this subject matter cannot become part of its divisional application.

This post was written by Lisa Mueller and Verena Simpson, Lars Pallisgaard Olsen and Annette Sorensen of Guardian IP.

Europe: Use of “Veggie Burger” is Okay but “Vegan Cheese” is Not

October 25, 2020

Background

In Europe, Regulation (EU) No. 1308/2018 (Regulation) establishes a common organization of markets for agricultural products.  Article 78 of the Regulation states that the terminology and naming conventions (such as definitions, designations, and sales descriptions) for various sectors and products, such as meat and milk and milk products intended for human consumption are provided in Annex VII.  Part III of Annex VII specifically reserves the use of the terms “milk”, “cheese”, “yoghurt”, “butter” or “whey” exclusively to products that contain dairy “milk” (which is defined as “…the normal mammary secretion obtained from one or more milkings without either addition thereto or extraction therefrom”).  However, the Regulation does not contain any provision that reserves the use of the terms “steak”, “sausage”, “escalope”, “burger” or “hamburger” exclusively for products that contain meat.

Amendment 165 and 171

Late in the day on Friday of last week, members of the European Parliament (MEP) cast their final votes on two amendments relating to the use of dairy-like and “meaty” terminology for plant-based products that would have amended certain portions of Parts I and III of Annex VII of the Regulation.  Interestingly, the MEPs took different positions on the two somewhat similar proposals.  Specifically, the MEPs voted against Amendment 165, which would have amended Part I to prohibit terms like “steak”, “sausage”, “escalope”, “burger” or “hamburger” from use with plant-based (vegetarian and vegan) products.  However, the MEPs voted for Amendment 171, which amends Part III to ban terms like “vegan cheese” as well as “butter-style”, “yogurt-style” and “cheese-style” for dairy-free products.  Thus, as a result, plant-based alternatives will not be able to carry any dairy-related terms.

The vote on Amendment 171 follows a 2017 ruling from the European Court of Justice that banned the use of dairy terms like “milk”, “butter”, “cheese” and “yogurt” for purely plant based products (e.g., tofu) with the exception of coconut milk, peanut butter, almond milk and ice cream.  Not surprisingly, the European Dairy Association lauded the vote stating that “Non-dairy products cannot hijack our dairy terms and well-deserved reputation of excellence in milk and dairy.”  Opponents to Amendment 171 point out that the ban appears to contradict the European Green Deal objectives and the Farm-to-Fork Strategy which both aim to create healthier and more sustainable food systems.

It will be fascinating to watch the implementation of Amendment 171 in the EU.  Although the purpose of Amendment 171 is to prevent customer confusion, by voting against Amendment 165, it seems likely that some customer confusion will result.  Only time will tell.

This post was written by Lisa Mueller

The Doctrine of Equivalents: Examination of the Law in Denmark

November 20, 2019

In many jurisdictions, the scope of protection afforded by a patent is defined by the claims as read either literally or under doctrine of equivalents.  Infringement based on the doctrine of equivalents is generally not based on any statutory law but rather has been established via case law (e.g. Court decisions).  The purpose of the doctrine of equivalents is to promote fair patent coverage so that trivial departures (e.g., variants or deviations) from the claim language cannot be used to avoid infringement. 

This is the fourth post in our series examining the law governing the doctrine of equivalents in several European countries.  Our first post examined the law governing the doctrine of equivalents in Spain, our second post examined the law in the Netherlands, and our third post examined the law in Germany.  These posts can be viewed here:  Doctrine of Equivalents – Spain, Doctrine of Equivalents – the Netherlands, and Doctrine of Equivalents – Germany.

Doctrine of Equivalents in Denmark

Background

Despite its somewhat small size, Denmark is a fairly litigious country when it comes to patent litigation.  Some reasons for this are:  the cost of litigation is not extremely high and Denmark is a highly technically developed country with many specialized industries (such as, for example, pharmaceuticals).  In Denmark, courts are organized in a three-tier system comprising: (a) city courts; (b) two high courts (the Eastern and Western High Courts) and the Maritime and Commercial High Court; and (c) the Supreme Court.  Most patent proceedings, including proceedings for preliminary injunctions, are decided by the Maritime and Commercial High Court in Copenhagen (Maritime Court), as the court of first instance.  Appeals from the Maritime Court are to the Eastern High Court, and in some instances, the Supreme Court. 

As the main venue for patent cases, the Maritime Court can be considered to be a specialized patent court that having significant expertise in patent matters. Generally, cases before the Maritime Court are heard by a permanent law judge with a law degree and two technically qualified judges (who each may have a law degree) who are individuals with relevant commercial and/or technical backgrounds and/or experience.  The proceedings are generally conducted in Danish and infringement and validity claims are heard simultaneously (i.e., there is no bifurcation).  In addition to patent cases, the Maritime Court hears other commercial cases such as trademarks, designs, contracts, labor rights, bankruptcy, maritime law, etc., but no criminal cases.

Claim Construction

According to Article 69 European Patent Convention (EPC) the extent (“the scope”) of the protection conferred by a European patent or application is determined by the claims.  Nonetheless, the description (i.e., specification) and drawings are also considered when interpreting the claims.  Specifically, in Denmark, the claims are construed to determine the “essential” or “significant” features or parts of the invention.  Language in the claims that is not relevant to the “essential” or “significant” parts of the invention (e.g., namely, non-essential features) may be given less or very little weight when assessing the scope of protection. 

Statements made by the patentee during examination (i.e., prosecution) can be relevant to claim construction, particularly if made for purposes of avoiding prior art (e.g., novelty and/or inventive step).  Thus, as will be discussed in further detail herein, prosecution history estoppel may apply in Denmark both in the context of construing the claims as well as in the application of equivalency under the doctrine of equivalents.   

Patent Infringement

The protocol for interpreting Article 69 EPC, which is an integral part of the EPC according to Article 164(1) EPC, states:

Article 1 – General principles

Article 69 should not be interpreted as meaning that the extent of the protection conferred by a European patent is to be understood as that defined by the strict, literal meaning of the wording used in the claims, the description and drawings being employed only for the purpose of resolving an ambiguity found in the claims. Nor should it be taken to mean that the claims serve only as a guideline and that the actual protection conferred may extend to what, from a consideration of the description and drawings by a person skilled in the art, the patent proprietor has contemplated. On the contrary, it is to be interpreted as defining a position between these extremes, which combines a fair protection for the patent proprietor with a reasonable degree of legal certainty for third parties.

Article 2 – Equivalents

For the purpose of determining the extent of protection conferred by a European patent, due account shall be taken of any element which is equivalent to an element specified in the claims.

The protocol for interpreting Article 69 EPC is applicable to granted European patents validated in Denmark. However, according Article 64(3) EPC, the question of infringement of a European patent is dealt with under national, namely, Danish law.

Similar to Article 69 EPC, Section 39 of the Danish Patent Act (DPA) stipulates that:

The extent of the protection conferred by the patent and the patent application shall be determined by the patent claims. For the interpretation of the claims the description may serve as a guide.

Article 3 of the DPA defines what acts are not to be performed by third parties, i.e., what acts can potentially constitute infringement.  Specifically, according to this article:

…without permission of the patent owner, no one may exploit the invention by making, offering, putting on the market or using a product that is the subject matter of the patent, by importing or possessing a product for these purposes, by using a process that is the subject matter of the patent or by offering the process for use in Denmark, if the person offering the process knows or it is obvious in the circumstances that the use of the process is prohibited without the permission of the patent owner, or by offering, putting on the market or using a product obtained by a process that is the subject matter of the patent, or by importing or possessing the products for these purposes. 

There are two major types of patent infringement in Denmark: 1) literal infringement; and 2) infringement under the doctrine of equivalents. In order to assess whether infringement has occurred it is first necessary to interpret the terms used in the claims as discussed previously herein.  Once the meaning of the claims has been construed, a determination is made whether the claims have been literally infringed, before moving on to determine whether the claims have been infringed by equivalence.  Of course, an assessment of infringement under the doctrine of equivalents is only made when literal infringement has not been found.

Literal infringement

In Denmark, literal infringement requires an analysis of whether each and every essential or significant part of the invention can be found in the alleged infringing product or process.  If each and every essential or significant feature or part of the invention cannot be found in the alleged infringing product or process, namely, if deviations exist between the essential or significant features or parts of the invention and the alleged infringing product or process, then there can be no finding of literal infringement and the analysis moves to whether or not infringement exists under the doctrine of equivalents.

Infringement under the Doctrine of Equivalents and Prosecution History Estoppel

Under the doctrine of equivalents, if deviations exist between the essential or significant features or parts of the invention and the alleged infringing product or process, a determination must be made whether the deviations would be an obvious alternative recognized by one skilled in the art to be useful for the same purpose as the essential or significant feature or part recited in the claims. It is a fundamental premise that the protection afforded under the doctrine of equivalents reflect a balance between clarity and fairness. Specifically, the analysis involves determining whether the deviation (1) performs the same function in the same way as the essential or significant feature or part recited in the claim in order to solve the same problem as the claimed invention; (2) would be recognized by one skilled in the art as being an obvious alternative to the essential or significant feature or part recited in the claim; and (3) was not specifically excluded during examination (namely, the allegedly infringing product or process  must not belong to the prior art). 

As mentioned above, one limitation on equivalency in Denmark is the doctrine of prosecution history estoppel.  Generally, the Maritime Court will review statements and/or amendments made by the patentee during examination.  Statements made by the patentee to the effect that a certain embodiment is not covered by the scope of the claims will usually be binding.  Likewise, arguments and/or amendments made to claims to overcome novelty and/or inventive step rejections will preclude a finding of infringement under the doctrine of equivalents. 

The High Court decision U 2009/1523 (Guldager) set the direction for a more international approach toward applying Article 69 EPC which has been followed in several recent cases. An examples of a case in the life science area involving the doctrine of equivalents are:  Maritime Court decision A-19-17 (Eli Lilly and Company and Eli Lilly Danmark A/S v. Fresenius Kabi AB v/Fresenius Kabi and Fresenius Kabi Oncology Plc.), concerning Eli Lilly’s DK/EP 1 313 508 relating to the use of pemetrexed in combination with vitamin B12 and optionally, folic acid (covering the product Alimta®). 

This post was written by Lisa Mueller of Casimir Jones, and Lars Pallisgaard Olsen and Verena Simpson of Guardian IP Consulting.

The Federal Court of Justice is 1-1 in Granting Applications for Compulsory Licenses in Germany

June 27, 2019

On June 4, 2019, the tenth senate of the Federal Court of Justice (FCJ) confirmed the German Federal Patent Court’s (FPC) rejection of an application for a preliminary compulsory license to Amgen’s European Patent No. 2 215 124 (the ‘124 patent) covering the drug Repatha® (evolocumab).  Repatha®, a monoclonal antibody that inhibits the proprotein convertase subtilisin-kexin type 9 (PCSK9) protein, is used to reduce low density lipoprotein (LDL) cholesterol levels in blood.  Repatha® is particularly helpful in patients with persistently high cholesterol levels who do not benefit from statins such as Lipitor® (Pfizer, Inc.).  The ‘124 patent survived an opposition at the European Patent Office and was maintained as amended.

Sanofi’s developed its own anti-PSCK9 monoclonal antibody, Praulent® (alirocumab), also for use in reducing LDL cholesterol.  Both Repatha® and Praulent® were approved in Europe in late 2015.

After Sanofi began distributing Praulent® in Germany, Amgen filed a lawsuit for patent infringement in the Regional Court (Landgericht) in Düsseldorf (Docket No. 4c O 39/16), requesting among other things, injunctive relief.  In response, Sanofi filed an application in the FPC for a compulsory license under § 24 Patent Act (PatG) and, preliminary permission to use the invention for the drug Praulent® in four specific forms via preliminary injunction pursuant to § 85 of the PatG.

By way of background, § 24 of the PatG states:

“The non-exclusive right to industrial use of an invention is granted by the patent court in individual cases in accordance with the following regulations (compulsory license), provided that

1.1.1     The licensee has unsuccessfully sought, after a reasonable period of time, to obtain the consent of the patentee to use the invention on reasonable commercial terms; and

1.1.2     The public interest requires the grant of a compulsory license.”

Additionally, § 85 of the PatG states:

“In the proceedings for the grant of a compulsory license, the plaintiff may be allowed, at his request, the use of the invention by injunction if he can show credibly that the requirements of Section 24 Abs. 1 to 6 and that the granting of the permit in the public interest is urgently required.”

The FPC rejected Sanofi’s request for a preliminary injunction.  Specifically, the Court stated that Sanofi failed to make sufficient efforts during a reasonable period of time to obtain a license to the ‘124 patent.  Additionally, the public interest did not urgently require the granting of the preliminary injunction because Praluent® did not have superior therapeutic properties when compared to Repatha®, particularly, in the reduction of the risk of mortality.

The FCJ affirmed the FPC.   In agreeing with the FPC with respect to Sanofi’s lack of sufficient efforts to obtain a license to the patent within a reasonable time period,  the FCJ noted that Sanofi expressed its interest in a license from Amgen at a very late stage, offered only to pay a very low royalty rate, failed to respond to communications from Amgen regarding the matter and, when it did respond, only did so during the appeal proceedings in the ‘124 patent.  Additionally, the FCJ held that the public interest did not warrant granting the compulsory license because there was no credible evidence demonstrating that Praluent® offered any tangible therapeutic advantages over Repatha®.  Moreover, the FCJ did not find it credible that the administration of Praluent®, when compared with Repatha®, reduced the mortality rate of hypercholesterolemia in patients.  Finally, the FCJ did not find that the possible administration of Praluent® at a lower dose justified the granting of a compulsory license.

This is the second case involving a compulsory license decided by the FCJ in the last two years.  On July 11, 2017, the FCJ in decision X ZB 2/17 confirmed the granting of a compulsory license to Merck to European Patent No. 1 422 218 (‘218 patent) owned by Shionogi.  The compulsory license allowed Merck to continue to distribute its HIV drug raltegravir (marketed as Isentress®) in the German market.

After a year of license negotiations between the parties failed, Shionogi sued Merck for patent infringement before the Regional Court (Landgericht) in Düsseldorf.  In response, Merck filed for compulsory license proceedings before the FPC requesting a license based on § 24 PatG.  Several months later, Merck requested the compulsory license be granted by way of a preliminary order. On August 31, 2016, the FPC preliminarily granted the license, allowing Merck to continue distributing raltegravir.

In affirming the FPC, the FCJ found that HIV-infections were both infectious and lethal and a “serious disease”.   Although alternative compounds were available on the market (such as dolutegravir (Tivicay®)), experts appointed by the Court confirmed that the replacement of raltegravir with another drug was not acceptable given the potential life-long side effects and disadvantageous drug interactions that could result from the exchange.  Moreover, the experts also demonstrated that raltegravir was particularly advantageous in the post-exposure prophylaxis and in the treatment of certain patient groups (e.g. babies, infants, pregnant women and long-term patients). As a result, the public interest outweighed Shionogi’s interest in the exclusive exploitation of the ‘218 patent.

One particularly interesting issue that arose during the proceedings was determining what the scope of the compulsory license right should be, namely, whether the use of raltegravir should be restricted to specific patient groups.  This was a particularly complicated question as noted by the FPC:

“In view of a multitude of actors, which – each individually – decide if a certain patient in his individual situation requires raltegravir or not is not a criteria that can establish ‘in advance’ in a specific group of patients …This does not allow for limiting the patient group.  Already, for that reason, a limitation of the right to use for a life-saving drug is not possible.”  (Decision 3 LiQ/16, GRUR 2017, 373 382 at nr. 127).

While specific restrictions were not imposed, the right to use was limited to products already on the market.

In view of these two recent cases, the question is whether compulsory licensing will start to become a strategic tool used during patent litigation in Germany.  The answer is maybe – time will tell.  However, based on the decisions to date, what we can glean is that the FPC appears to be leaning towards granting compulsory license requests only in exceptional cases.

Not surprisingly, compulsory license proceedings present benefits and risks for the parties involved.  For the party seeking the license (license seeker), they will need to show consistent efforts to obtain a license.  If licensing talks fail after an adequate time, they will bear the burden of proof of establishing public interest in the compulsory license proceedings. Additionally, the license seeker will need to show that its product provides a tangible advantage over other available treatment options. In contrast, the patentee, if it loses and a compulsory license is granted, could be faced with the risk of having to allow a potential competitor to use his patent broadly, with no limitations as to, for example, patient groups.

This post was written by Lisa Mueller.

 

Tadalafil Patent Found Valid by Danish Maritime and Commercial High Court

July 18, 2018

Eli Lilly and Company (Eli Lilly) globally markets its product tadalafil (Cialis®) a PDE5 inhibitor, for use in the treatment of erectile (or sexual) dysfunction as well as for treating the signs and symptoms of benign prostatic hyperplasia.   Tadalafil is available as a tablet in four strengths – 2.5 mg, 5 mg, 10 mg and 20 mg, respectively.   Not surprisingly, worldwide, Eli Lilly has several issued patents covering tadalafil.  One such patent, European Patent No. 1 173 181 T6 (the ‘181 patent), covers a pharmaceutical unit dosage composition comprising 1 to 5 mg of tadalafil that is suitable for oral administration up to a maximum of 5 mg per day.

Over the last several years, there has been significant interest by generic manufacturers in developing a generic version of tadalafil.  As a result, in Europe, the ‘181 patent has already been litigated in several countries and been found to be invalid by courts in the Netherlands, Great Britain (on appeal to the Supreme Court) and Germany.  In Belgium, a nullity action is currently pending (despite the fact that a trial took place a few months ago, the parties are still waiting to receive a judgment).

Sandoz has launched a generic version of tadalafil in a few countries around the world, most recently in Denmark, where the product was made available in all strengths.  As a result, Eli Lilly filed a patent litigation action and a request for preliminary injunction with respect to the 2.5 mg, 5 mg and 10 mg tablets.  On June 15, 2018, the Danish Maritime and Commercial High Court, in Eli Lilly and Company, ICOS Corporation, and Eli Lilly Danmark A/S v. Sandoz A/S found the Danish equivalent of the ‘181 patent valid and issued the injunction.

During the proceeding, Sandoz argued that the preliminary injunction should not be granted because the ‘181 patent was invalid for added subject matter, lack of priority, lack of novelty and lack of inventive step.  However, the main focus of Sandoz’s arguments during the proceeding centered on lack of inventive step.  Specifically, Sandoz argued that the ‘181 patent was obvious in view of WO 97/03675 (Daugen II) and Viagra® (a well known PDG5 inhibitor).  In finding that the ‘181 patent was likely valid, the Court described the objective problem to be solved as providing a selective, potent tetracyclic derivative as described in Daugen II for the inhibition of PDE5 for treating erectile dysfunction as well as providing an improved dosing regimen. According to the Court, the “skilled person” would have consisted of a “team”, namely, a clinician as well as persons with knowledge about toxicology, pharmacokinetics, urology and pharmaceutical formulations.  Eli Lily argued that this team would have been lead by a clinician.  In contrast, Sandoz argued that the team would have been lead by a clinical pharmacologist.

According to the Court, the ‘181 patent solved the problem through the use of a unit dosage comprising 1 to 5 mg of tadalafil in the manufacture of a medicament for administration up to a maximum total dose of 5 mg tadalafil per day in a method of treating sexual dysfunction.  Specifically, the Court said that the general route of determining the optimal dose of a drug to administer does not in and of itself constitute inventive step.  However, this simply was not the case here.  Instead, the Court found that the recitation in the claims of a unit dose comprising 1 to 5 tadalafil up to a maximum of 5 mg daily did not lack inventive step in view of Daugan II.  Therefore, based on the evidence presented, the Court stated that one could not determine in advance of the clinical trials that a skilled person would have been lead to the claimed invention, and moreover, a computer model could not have sufficiently described the complicated conditions of the patent including the physical and psychological factors that can play a role in erectile dysfunction.  In fact, in view of what was known about Viagra®, the skilled person would have concluded that the higher the dose of tadalafil used the better the effect (in treating sexual dysfunction).  As a result, a skilled person would not have included a 5 mg or less dose in a dose response study and therefore would not have tried to develop a daily dosing regimen for treating sexual dysfunction.  Additionally, the Court found it surprising that tadalafil could be use daily at such an effective low dose with minimum side effects.

This post was written by Lisa Mueller and Verena Simpson of Guardian IP.